A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688)

NCT01617187 | Completed Phase 3 Results

• 2 other identifiers: P056882010-018407-28
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this trial is to assess the effect of asenapine 2.5 and 5 mg sublingually twice daily (BID) compared with placebo in the treatment of schizophrenia (overall symptoms) as measured by the Positive and Negative Syndrome Scale (PANSS). Olanzapine administered 15 mg orally once daily (QD) was used as an active control. The primary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the change from Baseline in the PANSS total score at Day 42. The first key secondary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the change from Baseline in Clinical Global Impression Scale-Severity (CGI-S) score at Day 42. The second key secondary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the rate of PANSS responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in PANSS Total Score at Day 42

  The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values.

  Baseline and Day 42

Secondary Outcomes (15)

• Change From Baseline in CGI-S Score at Day 42

  Baseline and Day 42

• Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42

  Baseline and Day 42

• Change From Baseline in Body Weight at Day 42

  Baseline and Day 42

• Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35

  Baseline and Days 4, 7, 14, 21, 28 and 35

• Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35

  Days 4, 7, 14, 21, 28 and 35

Study Arms (4)

Asenapine 2.5 mg BID

EXPERIMENTAL

Drug: Asenapine; Drug: Placebo Olanzapine

Asenapine 5 mg BID

EXPERIMENTAL

Drug: Asenapine; Drug: Placebo Olanzapine

Olanzapine 15 mg QD

ACTIVE COMPARATOR

Drug: Placebo Asenapine; Drug: Olanzapine; Drug: Placebo Olanzapine

Placebo BID

PLACEBO COMPARATOR

Drug: Placebo Asenapine; Drug: Placebo Olanzapine

Interventions

Asenapine DRUG

2.5 mg or 5 mg fast dissolving active asenapine tablets administered sublingually

Asenapine 2.5 mg BID; Asenapine 5 mg BID

Placebo Asenapine DRUG

Fast dissolving placebo asenapine tablets (to match 2.5 mg and 5 mg active asenapine tablets) administered sublingually

Olanzapine 15 mg QD; Placebo BID

Olanzapine DRUG

5 and 10 mg film-coated active olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding

Olanzapine 15 mg QD

Placebo Olanzapine DRUG

Film-coated placebo olanzapine tablets (to match 5 and 10 mg active olanzapine tablets) administered orally

Asenapine 2.5 mg BID; Asenapine 5 mg BID; Olanzapine 15 mg QD; Placebo BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current diagnosis of schizophrenia of paranoid, disorganized, or undifferentiated subtype
• Minimum PANSS total score of 70 at Screening and Baseline
• Score of at least 4 (moderate) in two or more of the five items in the positive subscale of the PANSS
• Confirmed to be experiencing an acute exacerbation of schizophrenia
• CGI-S scale score of at least 4 (moderately ill) at Baseline
• Has responded positively to an antipsychotic medication other than clozapine (Clozaril®) in a prior episode

You may not qualify if:

• Body mass index (BMI) \<18.5 or \>40.0 kg/m\^2
• Laboratory and/or clinical evidence of clinically significant hepatic conditions
• Known history of, or undergoing treatment for, narrow angle glaucoma
• Diagnosed with epilepsy or has had any seizure disorder beyond childhood febrile seizures
• Known serological evidence of human immunodeficiency virus (HIV) antibody
• History of neuroleptic malignant syndrome or tardive dyskinesias
• Past or current diagnosis of schizoaffective disorder, schizophrenia of residual subtype, schizophrenia of catatonic subtype, current diagnosis of schizophrenia with course specifiers continuous, single episode in partial remission, or single episode in full remission, or borderline personality disorder

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Landbloom R, Mackle M, Wu X, Kelly L, Snow-Adami L, McIntyre RS, Mathews M, Hundt C. Asenapine for the treatment of adults with an acute exacerbation of schizophrenia: results from a randomized, double-blind, fixed-dose, placebo-controlled trial with olanzapine as an active control. CNS Spectr. 2017 Aug;22(4):333-341. doi: 10.1017/S1092852916000377. Epub 2016 Nov 8.

  PMID: 27821210 RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

asenapine; Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2012
• First Posted: June 12, 2012
• Study Start: December 4, 2012
• Primary Completion: August 11, 2014
• Study Completion: September 9, 2014
• Last Updated: June 18, 2024
• Results First Posted: August 31, 2015

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share